National Research Council Strongly Objects to OMB Risk Assessment Bulletin

A Jan. 11 National Research Council (NRC) report found the Office of Management and Budget's (OMB) Proposed Risk Assessment Bulletin to be "fundamentally flawed." The report contained concerns similar to those raised by OMB Watch and Public Citizen in comments submitted in August 2006. OMB asked NRC to review the document after its release in January 2006. NRC suggested the Bulletin be withdrawn completely. Following the release of the report, OMB announced that it will go back to the drawing board to "develop improved guidance for risk assessment."

The Bulletin contained a set of guidelines to govern all risk assessments and included technical standards for all federal agencies to use when conducting risk assessments, as well as other scientific documents. The OMB guidelines would apply to risk assessments conducted as part of issuing or revising health, safety and environmental rules, as well as important scientific studies.

The Council found that OMB's new definition of risk assessment was "too broad and in conflict with long-established concepts and practices." The Bulletin defined a risk assessment as a document instead of a process and the goals outlined, when considered together, indicated "that a risk assessment should be tailored to the specific need for which it is undertaken." The emphasis, according to the NRC evaluation, was on efficiency over quality and stated that the goals outlined did not "support the primary purpose of the bulletin — to enhance the technical quality and objectivity of risk assessments."

The report also recommended that OMB leave technical risk assessment guidelines and standards to each federal agency because one size does not fit all when it comes to risk assessments. The Council stressed concerns over "the likely drain on agency resources, the extended time necessary to complete risk assessments that are undertaken, and the highly likely disruptive effect on many agencies."

As OMB has done with other regulatory tools, the risk assessment approach called for in this release would have created unnecessary delays in the rulemaking process by adding to the already cumbersome process that OMB oversees. The ability of government agencies to protect the public would be compromised by attempts to manipulate science and the risk assessment process. For example, the proposed standards called for the use of central estimates or tendencies instead of statistical ranges. Using this approach puts the most vulnerable populations, who fall outside these "central estimates," at risk in some analyses.

In May 2006, the NRC held a public meeting at which it took comments from a range of organizations interested in the Risk Assessment Bulletin. OMB Watch, the Natural Resources Defense Council, Resources for the Future, and several medical experts gave presentations regarding the impacts of OMB's risk standards. Also submitting comments were representatives from several federal agencies who conduct risk assessments. The NRC used these comments and their own analysis to reach the conclusions in the report.

The rebuke by the NRC is one of the strongest commentaries issued on the trend over the last six years to centralize power over the regulatory process within OMB and move it away from agencies responsible for protecting health, safety and the environment. The administration has consistently used regulatory tools to manipulate science for its own ends, attempted to impose a one-size-fits-all framework on the agencies' use of these tools, and shift the criteria for defining when regulations are necessary away from a health or safety problem and toward market-based criteria. The strongly-worded NRC evaluation should provide a Congress interested in executive oversight with a strong example of the dangers of this regulatory trend.